MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 3.5NEF

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

A report was received that stated the tip of the tracheostomy tube had been cut unnaturaly.There was no report of patient involvement.

Manufacturer Narrative

The serial number / lot number was not provided by the customer.Covidien has requested additional information.(b)(4).

Manufacturer Narrative

(b)(4).The reported failure of the tracheostomy tube distal tip was unevenly cut was verified.The source of the device problem occured at the manual assembly process.The manufacturing work instructions have been updated, and assembly operators have been retrained to the work instructions.

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4173997
• MDR Text Key: 21932523
• Report Number: 2936999-2014-00894
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.5NEF
• Device Catalogue Number: 3.5NEF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1